510(k) clearances

Premarket notifications cleared by FDA, newest decision first.

Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.

Data as of 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 ingested clearances have a decision year between 2012 and 2026, the 15 years shown, 2023 the highest year at 3,346.

Show the numbers

510(k) clearances by decision year, the last 15 years of ingested records
Year	Clearances
2012	3,135
2013	3,052
2014	3,202
2015	3,020
2016	2,956
2017	3,200
2018	3,062
2019	2,918
2020	2,923
2021	3,023
2022	3,209
2023	3,346
2024	3,129
2025	3,225
2026	2,618

176,415 records, page 2968 of 3529

510(k) clearances, page 2968 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K852604	Muscle Minder: Heat Wrap W/ Hot + Cold Pack	Clairol, Inc.	IRT	Class II	1985-08-12
K852537	T-3 Riassay	Ria Diagnostics	CDP	Class II	1985-08-12
K852519	Dupont Aca Fibrin Degradation Prod Clotting Tube	E.I. Dupont de Nemours & Co., Inc.	JCO	Class II	1985-08-12
K852484	Plastinex	Bio/Data Corp.	GJS	Class II	1985-08-12
K852449	Howmedica Hip Sys Distal Centralizing Spacer	Howmedica Corp.	LZN	Class II	1985-08-12
K852398	Vector Bar Suspension/traction Unit	Powlan Manufacturing Co.	ILZ	Class I	1985-08-12
K852195	Cephalinex Activated Ptt Reagent	Bio/Data Corp.	GGW	Class II	1985-08-12
K852176	Dupont Aca Fibrin Ogen Degrad-Products Calibrator	E.I. Dupont de Nemours & Co., Inc.	GHH	Class II	1985-08-12
K852032	Ocular Pressure Reducer (Mccannel)	Visitec Co.	LCC	Class II	1985-08-12
K851323	Amendment William Harvey H-4300 Cardiopulmonary Su	C.R. Bard Inc	DWF	Class II	1985-08-12
K850950	Vision Potassium	Abbott Medical	CEM	Class II	1985-08-12
K844775	Effner-Eye Cautery with Battery Handle	Mecron Medical Products, Inc.	HQO	Class II	1985-08-12
K853135	Visitec 2 Micron Fluid Filter	Visitec Co.	HQE	Class II	1985-08-09
K853110	Spectacle Prescription Lenses	Ancie Laboratories	HQG	Class I	1985-08-09
K853079	Protective Pad for Incontinence	I.C.D. Industries, Inc.	EYQ	Class I	1985-08-09
K852956	Contact Conductive Adhesive Gel Composition	Parker Laboratories, Inc.	GYB	Class II	1985-08-09
K852793	Ureteral Dilator/sheath Set	American Edwards Laboratories	EZN	Class II	1985-08-09
K852679	Multiple(hemorx) If Approved by Trademark Office	J. & Jp., Inc.	LKX	Unclassified	1985-08-09
K852592	CO2 for Arthroscopy	The Anspach Effort, Inc.	HRX	Class II	1985-08-09
K852479	Pulmonary Vein Clamp	None	DXC	Class II	1985-08-09
K852399	Total Cpm	Invacare GmbH	BXB	Class I	1985-08-09
K852397	External Fixation System(cat. # Serias 5129)	Howmedica Corp.	JEC	Class II	1985-08-09
K852363	Mic Gastrostomy Tube Percutaneous Insertion Kit	Medical Innovations, Inc.	KNT	Class II	1985-08-09
K852351	Kirschner Self-Tapping Acetabular Cup	Kirschner Medical Corp.	KWA	Class III	1985-08-09
K852271	Cavitron/kelman Phaco-Emulsifier Aspirator, 9001	CooperVision, Inc.	HQE	Class II	1985-08-09
K852232	Pressure Display Box #60000/Tubing Set #61000	Dlp, Inc.	DXS	Class II	1985-08-09
K852226	Believe Labial Pads	Kimberly-Clark Corporation	HHD	Class I	1985-08-09
K852177	Foam ECG Electrodes	Clinical Data, Inc.	DRX	Class II	1985-08-09
K852099	Bard-Parker Irrigation Catheter	BD Becton Dickinson Vacutainer Systems Preanalytic	DQY	Class II	1985-08-09
K852086	Capiox Blood Sampling Manifold	Terumo Medical Corp.	DTL	Class II	1985-08-09
K852069	Mecta Ect Device Models Sr & Jr	Mecta Corp.	QGH	Class II	1985-08-09
K851897	Ccs Model Av-106 Implantable a-V Data Lead	Cardiac Control Systems, Inc.	DTD	Class II	1985-08-09
K850605	Radi-Biopsy Device	Radiplast AB	KNW	Class II	1985-08-09
K853066	Mayfield Disposable Skull Pins	Cerenovus, Inc.	HAX	Class II	1985-08-08
K852934	Precision - Cosmet Capsule Coupeur	Precision-Cosmet Co., Inc.	HNY	Class I	1985-08-08
K852834	Ortho Hematology Cont 14 Normal, 14 Abnormal H & L	Ortho Diagnostic Systems, Inc.			1985-08-08
K852830	Sunny Sun Magnifying Glasses	Sunny Optical Co., Ltd.	HQY	Class I	1985-08-08
K852792	Corpak Enteral Sol Adm Pump Set W/ Screw	Corpak Co.	KNT	Class II	1985-08-08
K852773	Sunglasses	Pony Industries Co., Ltd.	HQY	Class I	1985-08-08
K852643	Uni-Plate	Medical Specialties Laboratories			1985-08-08
K852287	Percutaneous Pigtail Suprapublic Catheter Set	Cook Ob/Gyn	KOB	Class II	1985-08-08
K852127	Amsco Uro-Endo Mobile Table	American Sterilizer Co.	KQS	Class I	1985-08-08
K851874	Or Tube Restraint	KCI USA, Inc.	CBH	Class I	1985-08-08
K851525	Pfeiffer Pump	Ing. Erich Pfeiffer GmbH & Co. KG.	CCQ	Class I	1985-08-08
K843672	Q-Fever	Institute Virion, Ltd.	GPS	Class I	1985-08-08
K843654	Chlamydia	Institute Virion, Ltd.	GPW	Class I	1985-08-08
K853153	Medus Gmbh	Corkes Medical Co.	GEN	Class I	1985-08-07
K853056	Respir Gard-II Face Mask Corrugated Tubing	Marquest Medical Products, Inc.	IYT	Class II	1985-08-07
K853046	Tan Model I	Philip Munsterman Tan, Inc.	FTC	Class II	1985-08-07
K853021	Optimate Digoxin Test	Miles Laboratories, Inc.	DPB	Class II	1985-08-07